EU Authorised Representative service and UK Responsible Person service.

What is an ‘EU Authorised Representative’?

In the context of product compliance, an EU Authorised Representative (AR) is an individual or a business entity that acts as an authorised point of contact on behalf of a manufacturer that is based outside of the country for which the product is being sold (or placed on the market in most cases, even if a sale is not involved). So if you are located outside of the EU and wish to place your products on the EU market in one or more of the EU member countries, our EU AR cost-effective service will very likely be of interest. We can represent you for many kinds of products including consumer goods (though not cosmetics or liquids of any kind currently), consumer electronics, lighting, IT, audio-visual, industrial, renewable energy, power conversion, machinery, PPE, laboratory, test &measurement, toys, leisure industry (e.g. e-bikes, exercise machines, paddleboardsetc) and medical devices. 

In the case of an EU AR, the representative would be based in one of the 27 member states
(UK being a ‘third country’ from 1^st January 2021, so an EU AR can no longer be located in the UK). 

Is it mandatory to appoint an EU Authorised Representative (EU AR)? 

Under the Market Surveillance legislation EU 2019/1020, released in July 2019, all items falling under the scope of union harmonisation legislation (as identified in Article 4, paragraph 5 of the legislation) will need to have an EU economic operator and business name and address for surveillance purposes. An EU authorised representative is a form of an economic operator. 

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Products within the scope of EU General Product Safety Regulation 2023/988 (EU GPSR) do not require the CE mark, but since the regulation came into place on 13th December 2024, taking the place of EU GPSD, there are changes manufacturers need to be aware of. Under the EU GPSR, products must have a 'producer' who takes responsibility for placing the product on the market. A producer can be a manufacturer based within the EU, an importer based within the EU, or a 'manufacturer's representative' (authorised representative) based within the EU if the manufacturer is based outside. 

What is a UK Responsible Person, and is it mandatory to appoint one?

In the context of product compliance, a UK Responsible Person (UK RP) is an individual or a business entity that acts as an authorised point of contact on behalf of a manufacturer that is based outside the UK.

Medical device manufacturers, based outside the UK, who are placing their devices onto the UK market must appoint a UK RP. This is outlined in the UK MDR 2002. 

How do Product Approvals provide the EU AR service and the UK RP service?

Product Approvals' subsidiary companies, Comply Express Lda & Comply Express Ltd provide the EU Authorised Representative and UK Responsible Person services. 

Comply Express Lda, based in Portugal, has a licensed address which can be utilised on your product, packaging, or accompanying document. Comply Express Lda covers a variety of products.
Contact info@complyexpress.com for more information. 

Comply Express Ltd, based in England, offers a UK RP service to customers outside of the UK, licensing its name and UK contact details for use accordingly. We will act on your behalf to register certified medical devices with the UK MHRA (Medicines and Healthcare products Regulatory Agency). We can also represent you if desired for other product categories.
Contact info@complyexpress.com for more information.  

How do I get started?

Simply contact Product Approvals of Comply Express by email or phone to further your enquiry.

info@complyexpress.com
info@productapprovals.co.uk